Yaz, Yasmin Blood Clot Danger Getting Attention in Canada

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Health Canada announced it is conducting a safety review of Yaz and Yasmin birth control pills to evaluate the potential increased risk of blood clots compared to other contraceptives.

Both Yaz and Yasmin are the only drospirenone-containing birth control marketed in Canada, reported PharmPro.   Drospirenone is a type of female sex hormone called progestin.  

The ongoing review will include two recent studies published in the British Medical Journal that reported there is a two to three times increased risk of blood clots associated with using drospirenone-containing pills.

Health Canada said it will take appropriate action once the review is completed which includes informing healthcare professionals and Canadians of the updated safety information.

The federal department reminded healthcare professionals that patients with a history of blood clots and women over the age of 35 who smoke should not use birth control pills.  Blood clots are a rare side effect of birth control and can result in persistent leg pain, severe chest pain, shortness of breath and death.

A U.S. federal agency is also investigating the risks associated with Yaz and Yasmin.

In late May, the Food and Drug Administration (FDA) released a safety announcement as part of their ongoing safety review of drospirenone-containing birth control pills.  In announcing the review, the agency noted that information from four earlier studies, – two which indicated an increased blood clot risk and two that did not – are included on the Warnings and Precautions section of labels of Yaz and Yasmin.   Like its Canadian counterparts, the FDA is reviewing the birth control pills because of the findings from the two recent British Medical Journal studies.

The FDA’s ongoing review will also include the two recent studies and data from an FDA-funded study on hormonal contraceptives.  The agency sponsored study includes over 800,000 U.S. women and will look to determine risks of blood clots in various hormonal contraceptives; the results are expected to be published later this summer.